Controlled Environments
GMP Annex 1 · AEMPS · EMA · FDA · Full DQ/IQ/OQ/PQ
GMP environments with the full Contamination Control Strategy required by the revised Annex 1.
In detail
Building a pharmaceutical cleanroom is necessary. Passing a regulatory inspection is the real objective. Our GMP environments deliver the complete Contamination Control Strategy (CCS) required by the revised Annex 1 (EU, 2022): pressure cascades, segregation of personnel and material flows, validated gowning architecture, certifiable surface finishes. ICH Q7 for active pharmaceutical ingredients. ICH Q9 for risk management. GMP Annex 15 for qualification and validation. DQ/IQ/OQ/PQ as a standard deliverable.
Regulatory framework covered: Regulation (EU) 2023/1182 and GMP Annex 1, EMA guidelines, FDA 21 CFR Parts 210 and 211. For Spanish-speaking markets: AEMPS (Spain), COFEPRIS (Mexico), ANMAT (Argentina) and INVIMA (Colombia) — all with abbreviated pathways that recognise EMA and FDA as authorisation references. One documentation set. Every market.
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
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MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
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Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
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Pharmaceutical-grade purity. Industrial-scale economics. High-potency containment where both are needed at once.
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Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
See more →Sectores aplicables
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
See more →Sectores aplicables
Pharmaceutical-grade purity. Industrial-scale economics. High-potency containment where both are needed at once.
See more →Sectores aplicables
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
See more →Sectores aplicables
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
See more →Sectores aplicables
Pharmaceutical-grade purity. Industrial-scale economics. High-potency containment where both are needed at once.
See more →Sectores aplicables
